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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 021880


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NDA 021880 describes REVLIMID, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and three Paragraph IV challenges. Additional details are available on the REVLIMID profile page.

The generic ingredient in REVLIMID is lenalidomide. There are fourteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the lenalidomide profile page.
Summary for 021880
Tradename:REVLIMID
Applicant:Bristol Myers Squibb
Ingredient:lenalidomide
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 021880
Suppliers and Packaging for NDA: 021880
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REVLIMID lenalidomide CAPSULE;ORAL 021880 NDA Celgene Corporation 59572-402 59572-402-00 100 CAPSULE in 1 BOTTLE (59572-402-00)
REVLIMID lenalidomide CAPSULE;ORAL 021880 NDA Celgene Corporation 59572-402 59572-402-28 28 CAPSULE in 1 BOTTLE (59572-402-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Dec 27, 2005TE:ABRLD:Yes
Regulatory Exclusivity Expiration:May 28, 2026
Regulatory Exclusivity Use:INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
Regulatory Exclusivity Expiration:May 28, 2026
Regulatory Exclusivity Use:INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)
Regulatory Exclusivity Expiration:Feb 22, 2024
Regulatory Exclusivity Use:TREATMENT OF MULTIPLE MYELOMA (MM), AS MAINTENANCE FOLLOWING AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AUTO-HSCT)

Expired US Patents for NDA 021880

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-005 Dec 21, 2011 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-005 Dec 21, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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